Registration Dossier
Registration Dossier
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EC number: 201-557-4 | CAS number: 84-74-2
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, with certain restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 961
- Report date:
- 1961
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- only 7-day observation period
- Principles of method if other than guideline:
- BASF-Test
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Dibutyl phthalate
- EC Number:
- 201-557-4
- EC Name:
- Dibutyl phthalate
- Cas Number:
- 84-74-2
- Molecular formula:
- C16H22O4
- IUPAC Name:
- dibutyl phthalate
- Details on test material:
- - Name of test material (as cited in study report): dibutyl phthalate
- Physical state: colorless clear liquid
- Analytical purity: technical purity
No additional data provided
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gassner
- Age at study initiation: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
No additional data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
No additional data provided - Doses:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: body weight was determined before the start of the study for determination of dose. Animals were observed approximately 1-3 hours after dosing and then daily over a period of 7 days.
- Necropsy of survivors performed: yes; at necropsy, all rats were examined for gross pathological changes. No further details available. - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6 279 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: the LD50 was 6279.0 mg/kg bw (calculated from 6.0 ml/kg bw assuming test substance density of 1.0465 g/ml)
- Mortality:
- no data
- Clinical signs:
- other: no data
- Gross pathology:
- no data
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
